Atrial Fibrillation Clinical Trial
Official title:
Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial
Verified date | September 2018 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the safety, efficacy and efficiency of rapid anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT) monitoring in patients undergoing catheter based ablation of atrial fibrillation.
Status | Completed |
Enrollment | 153 |
Est. completion date | April 3, 2018 |
Est. primary completion date | November 16, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial fibrillation or atrial flutter (left atrial). - Age = 18 year - Patients who are mentally and linguistically able to understand the aim of the trial, comply with the trial protocol, verbally acknowledge the risks, benefits, and alternatives in this trial. Exclusion Criteria: - Previous intolerance or allergy to heparin products. - Current or prior administration of protamine products - History of femoral access site complications including hematoma, AV fistula, pseudoaneurysm, aneurysm. - Known lower extremity venous thrombosis. - Coagulopathy or blood dyscrasias. - Active malignancy. - Thrombocytosis (platelet count >600k/ul) or thrombocytopenia (platelet count <100k/ul) - Planned use of vascular closure device |
Country | Name | City | State |
---|---|---|---|
United States | Michigan Medicine | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Ambulation | Total length of time from procedural termination to patient ambulation | 0 to 24 hours | |
Secondary | Count of Participants Who Experienced Vascular Access Site Complications | Secondary endpoints will include the number of patients who experience a 90-day occurrence of vascular access site complications defined as hematoma formation, aneurysm, pseudoaneurysm, arteriovenous fistula formation, access-site related major bleeding (defined as Bleeding Academic Research Consortium (BARC) type 3a or 5), or procedural intervention for access complications (surgical repair, thrombin injection, et cetera) | checked at 30 and 90 days |
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